PACKAGE LEAFLET: INFORMATION FOR THE USER

DICLO-XL 100

[diclofenac sodium]

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, health care provider or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Diclo-XL 100 are and what they are used for

2.    Before you take Diclo-XL 100

3.    How to take Diclo-XL 100

4.    Possible side effects

5.    How to store Diclo-XL 100

6.    Further information

1.    What Diclo-XL 100 are and what they are used for

Diclofenac is one of the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Diclo-XL 100 may be used for the relief of pain and swelling in a wide range of chronic (long-term) (arthritis affecting the joints) conditions including arthritis (swelling of a joint), osteoarthritis and ankylosing spondylitis (arthritis affecting the spine and pelvis).

Diclo-XL 100 is specially formulated to release the active ingredient slowly, over a long period of time.

2.    Before you take Diclo-XL 100

Do not take if you have a peptic ulcer (ulcer in your stomach or duodenum) bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation.

If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:

•    Pass blood in your faeces (stools/motions)

•    Pass tarry black stools

•    Vomit any blood or dark particles that look like coffee grounds.

•    STOP TAKING the medicine and tell your doctor if you

experience: indigestion or heartburn, abdominal pain (pains in your stomach) or other abnormal stomach symptoms.

Do not take Diclo-XL 100 and tell your doctor if you:

•    Have a history of stomach bleeding or perforation which may be related to the use of NSAIDs (naproxen, ibuprofen, diclofenac) or aspirin.

•    Are hypersensitive (allergic) to Diclofenac or any other ingredients in this medicine (see section 6. Further information).

•    Have a history of allergy to aspirin, ibuprofen or NSAIDs, which includes attacks of asthma, swelling of the nose and throat, skin rashes or a runny nose.

•    Have inflammatory bowel disease.

•    Suffer from severe kidney, heart or liver disease

•    Suffer from epilepsy

•    Are in the last trimester of pregnancy

•    Are taking medicines for blood clots (for example warfarin)

•    If you established heart disease and/ or cerebrovascular disease e.g. if you have had a heart attack, stroke, ministroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear bypass blockages

•    If you have or have had problems with your blood circulation (peripheral arterial disease).

Take special care with Diclo-XL 100 and tell your doctor if you:

•    Suffer from asthma

•    Are an older person

•    Have System Lupus Erythematous (SLE or ‘Lupus') or other connective tissue disorders

•    Have ulcerative colitis or Crohn's disease

•    Have porphyria (enzyme deficiency affecting the chemicals responsible for blood production in the body).

Make sure your doctor knows, before you are given diclofenac:

•    If you smoke

•    If you have diabetes

•    If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.

Medicines such as Diclo-XL 100 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.

If you go into hospital to see a doctor or you have a dental appointment, tell them that you are taking Diclo-XL 100.

If you suffer from any blood or bleeding disorder your doctor may ask you to have regular check ups while taking these tablets.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Especially:

•    Aspirin, ibuprofen or other non-steroidal anti inflammatory drugs for pain relief (e.g naproxen, diclofenac)

•    Anticoagulants such as warfarin to prevent blood clots

•    Antihypertensives to treat high blood pressure

•    Methotrexate and ciclosporin used to treat rheumatoid arthritis and psoriasis

•    Corticosteroids used as anti-inflammatory treatments

•    Mifepristone (now or at any time in last 12 days)

•    Lithium used in the treatment of depression

•    Diuretics (water tablets) used to treat blood pressure and water retention

•    Digoxin used to treat heart problems

•    Phenytoin used to treat epilepsy

•    Sulphonylureas such as gliclazide or glibenclamide used to treat diabetes

•    Probenecid used to treat gout

•    SSRIs (Selective serotonin reuptake inhibitors) used to treat depression such as fluoxetine and paroxetine

•    Anti-platelet agents used to prevent blood clots from forming that can lead to heart attack or stroke e.g aspirin, clopidogrel, ticlopidine, dipyridamole

•    Tacrolimus used for immunosuppression

•    Zidovudine used in the treatment of AIDS and HIV infection

•    Trimethoprim used to prevent or treat urinary tract infections

•    Colestipol/cholestyramine used to lower cholesterol

•    Voriconazole used to treat fungal infections

•    Quinolone antibiotics used to treat infections.

Taking Diclo-XL 100 with food and drink

Always take the tablets with plenty of water, preferably with a meal. Try to take them at the same times every day.

Pregnancy, breast-feeding and fertility

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant, planning on becoming pregnant or are breast-feeding.

Diclo-XL 100 should not be taken in the last 3 months of pregnancy.

Diclofenac does pass into the mother's milk; therefore breastfeeding should be avoided if taking Diclo-XL 100.

Diclo-XL 100 may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving and using machines

Undesirable effects such as dizziness, drowsiness and tiredness and visual disturbances are possible after taking medicines of this type. If you are affected do not drive or operate machinery.

Important information about some of the ingredients of Diclo-XL 100

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Diclo-XL 100

Always take Diclo-XL 100 exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The lowest effective dose should be used for the shortest possible time.

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Adults (including older people):

The usual dose is 100mg (one tablet) daily, taken whole with plenty of water preferably with food or after food.

Older patients are more likely to experience side effects. Therefore treatment should be started on the lowest possible dose for the shortest possible duration. Your doctor should monitor your condition regularly.

Children: Not recommended

If you take more Diclo-XL 100 than you should

If you accidently take too many Diclo-XL 100 tablets, tell your doctor at once. If you can't do this, go to the nearest casualty department. Take along any tablets that are left, the container and the label so that the hospital staff can easily tell what medicine you have taken.

If you forget to take Diclo-XL 100

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Diclo-XL 100

Continue to take the tablets for as long as your doctor tells you to. Talk to your doctor if you have any concerns.

4. Possible side effects

Like all medicines, Diclofenac can cause side effects, although not everybody gets them.

Serious side effects:

If you suffer from any of the following side effects, STOP TAKING the tablets and seek immediate medical help:

-    Pass blood in your faeces (stools/motions)

-    Pass black tarry stools

-    Vomit any blood or dark particles that look like coffee grounds

-    STOP TAKING the medicine and tell your doctor if you experience: Indigestion or heartburn, abdominal pain (pains in your stomach) or other abnormal stomach symptoms.

Medicines such as Diclofenac may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

If you experience any of the following stop taking the tablets and contact your doctor immediately:

•    All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eye lids, face or lips, rash, reddening of the skin or itching (especially affecting your whole body)

•    Severe painful skin disorder with blisters and peeling skin. You may also have flu-like symptoms such as fever or sore throat (Steven's Johnson Syndrome)

•    Jaundice with symptoms of yellowing of eyes and skin

•    Diarrhoea (stop taking Diclo-XL 100 and do not take it again)

•    Blood disorders; you may have a persistent sore throat or high temperature, anaemia (feeling tired after exercising, giddiness, looking pale)

•    Respiratory problems: including inflammation of the lungs which causes breathlessness, cough and raised temperature and aggravated asthma.

The side effects listed below have also been reported. Common side effects (These may affect between 1 and 10 in every 100 patients):

•    Nausea, vomiting, wind, loss of appetite

•    Headache, dizziness, vertigo

•    Skin rash or spots

•    Raised levels of liver enzymes in the blood.

Rare side effects (These may affect between 1 in every 1000 to 1 in every 10,000 patients):

•    Gastritis (inflammation, irritation or swelling of the stomach lining)

•    Drowsiness, tiredness

•    Fluid retention, symptoms of which include swollen ankles

•    Liver function disorders, including hepatitis

•    Raised, itchy rash (Urticaria).

Very rare side effects (These may affect less than 1 in every 10,000 patients):

Effects on the nervous system:

Tingling or numbness in the fingers, tremor, blurred or double vision, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, mood changes, depression, anxiety, mental disorders, disorientation and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck, impotence.

Effects on the stomach and digestive system:

Constipation, inflammation of the tongue, mouth ulcers, inflammation of the inside of the mouth or lips, taste changes, lower gut disorders (including inflammation of the colon or worsening of ulcerative colitis or Crohn's disease, inflammation of the pancreas (pain, feeling sick and being sick).

Effects on the heart, chest or blood:

Palpitations (fast or irregular heart beat), chest pain, hypertension (high blood pressure), inflammation of blood vessels (vasculitis), heart disorders, including congestive heart failure, hypotension (low blood pressure, symptoms of which include faintness, giddiness or lightheadedness).

Effects on the liver or kidneys:

Kidney or severe liver disorders including liver failure, presence of blood or protein in the urine.

Effects on skin or hair:

Skin rashes which may be made worse by exposure to sunlight. Hair loss, itching, facial swelling.

Not known side effects (These cannot be estimated from the available data):

Confusion, hallucinations, malaise (general feeling of discomfort), inflammation of the nerves in the eye, disturbances in sensation.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Diclo-XL 100

Keep out of the sight and reach of children.

Keep the tablets in a dry place at normal room temperature (below 25° C) in the packaging they come in.

Do not use Diclo-XL 100 after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not use Diclo-XL 100 if you notice visible signs of deterioration.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further information

What Diclo-XL 100 contains.

The active substance(s) is Diclofenac sodium Ph Eur.

The other ingredients are:

Lactose Monohydrate Magnesium Stearate Hydrogenated vegetable oil type IUSNF (Sterotex)

Povidone K30 Talc

What Diclo-XL 100 looks like and contents of the pack

Description: White, circular, biconvex tablets

Contents of pack: Prolonged release tablets; Packs of

28 tablets.

Marketing Authorisation Holder and Manufacturer

Co-Pharma Limited

Unit 4, Metro Centre,    ^

Tolpits Lane, Watford, Herts, UK, WD18 9SS Tel: 01923 255580 Fax: 01923 255581

This leaflet was last revised in 09/2015.

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